23andMe and the FDA: what really drove them apart

What Really Drove 23andMe And The FDA Apart BY ROBERT SAFIAN, fastcompany.com Is getting a $99 DNA test really hazardous to your health? Our editor-in-chief decodes an innovation dustup. When we put 23andMe CEO Anne Woj­ci­c­ki on the cover of Fast Com­pa­ny’s Novem­ber issue, we didn’t expect the FDA to yank the com­pa­n… http://flip.it/UoyAS Related … Continue reading 23andMe and the FDA: what really drove them apart

FDA and 23andme: why they did it

Why The FDA Can’t Be Flexible With 23andMe, By Law David Kroll, forbes.com “One of the challenges is the world has been evolving and yet we have legislation that reflects a different era.”– Margaret Hamburg, Commissioner, U.S. Food and Drug Administration Almost a year ago, at the inau­gur­al Forbes… http://flip.it/690F3 Related articles Why The FDA … Continue reading FDA and 23andme: why they did it

FDA puts foot down on 23andme

No DNA Testing For You, Thanks to the FDA By Nick Gillespie, thedailybeast.com Per­son­al genet­ic tests are safe, inno­v­a­tive, and the future of med­i­cine. So why is the most trans­par­ent admin­is­tra­tion ever shut­ting down a cheap and pop­u­lar ser­vice? Because it can. In its infi­nite wis­dom, the Food and Drug… http://flip.it/Np3Bq Related articles Nick Gillespie: … Continue reading FDA puts foot down on 23andme

FDA reigning in medical apps

FDA to start reining in the Wild West of medical apps by Elizabeth Armstrong Moore, cnet.com The FDA says it is only regulating products that turn smartphones into medical devices it already oversees, such as apps that let your phone act as an electronic stethoscope or give feedback on CPR. The Wild West of mobile … Continue reading FDA reigning in medical apps

23andme: how to use genetic testing while ensuring privacy

How to use 23andMe without giving up your genetic privacy Sarah A. Downey, venturebeat.com Sarah A. Downey is an attor­ney, pri­va­cy ana­lyst, and writer at Abine, an online pri­va­cy start­up in Boston. Find her on Twit­ter @SarahADowney. If you’re like me, the idea of know­ing what’s in your genet­ic pro­file is both… http://flip.it/GpsmW Related articles … Continue reading 23andme: how to use genetic testing while ensuring privacy

Pesticides found in pregnant U.S. women in UCSF study – SFGate

Toxics found in pregnant U.S. women in UCSF study - SFGate. Related articles Flame Retardant Exposure Among Pregnant Women Drops in California Following Ban (counselheal.com)

FDA gives thumbs-up to latest fingertip EKG | Crave – CNET

FDA gives thumbs-up to latest fingertip EKG | Crave - CNET. Related articles FDA gives thumbs-up to latest fingertip EKG (news.cnet.com) more information on the ninth day at M.I.M (pediatricianfuture.wordpress.com) How EKG Courses Are Presented (basictelemetryclass.wordpress.com)

The American Society of Pharmacognosy

  pharmacognosy.us News & Announcements Jan­u­ary 3rd, 2013 “On New Year’s Eve of 2012, the US Food and Drug Admin­is­tra­tion (FDA) announced its approval of cro­fele­mer (Fulyzaq™, Salix Phar­ma­ceu­ti­cals, Ltd., Raleigh, North Car­oli­na) — mark­ing the sec­… http://flip.it/CYKFs The American Society of Pharmacognosy Related articles Salix Wins FDA Approval of Dragon's Blood Drug for Diarrhea … Continue reading The American Society of Pharmacognosy

FDA Approves Magnetic Helmet For Treating Depression

FDA Approves Magnetic Helmet For Treating Depression By Anya Kamenetz, fastcompany.com Today the Unit­ed States Food and Drug Admin­is­tra­tion approved a device that treats depres­sion using… mag­nets. About 14.8 mil­lion Amer­i­can adults, or 6.7 per­cent of the U.S. adult pop­u­la­tion, are diag­nosed with major depres­sion in … RT @FastCompany: FDA Approves Magnetic Helmet For Treating … Continue reading FDA Approves Magnetic Helmet For Treating Depression

FDA finally tries to regulate pharma social media, God Help Them

FDA Guidance on Responding to Unsolicited Requests for Off-Label Information pharma-mkting.com Two days after Christ­mas, on Decem­ber 27, 2011, while most of us were still on vaca­tion, the FDA qui­et­ly issued “Guid­ance for Indus­try Respond­ing to Unso­licit­ed Requests for Off-Label Infor­ma­tion About Pre­scrip­tion Drugs and Med­ical… RT @pharmaguy: FDA Guidance on Responding to Unsolicited Requests … Continue reading FDA finally tries to regulate pharma social media, God Help Them

33% of seafood is mislabeled in NYC

Study Finds A Third Of NYC’s Seafood Is Mislabeled, Posing Health Risks Mary Beth Quirk, consumerist.com (J Dailey)It isn’t just Los Angeles that is having a problem with mislabeled fish — a new study that tested seafood on menus, at grocery stores and in fancy specialty shops in New York City says plenty of the … Continue reading 33% of seafood is mislabeled in NYC

Drug companies return to nutritional supplements for innovation

(via Consumer, Drug Firms Vie in Vitamins - WSJ.com) Related articles We mistook drugs for food supplements: Ram Singh (thehindu.com) Myths In The Pricing Of New Drugs (forbes.com) Decreasing Diabetes Risk In Obese Children And Adolescents Through Vitamin D Supplementation (medicalnewstoday.com)

Gatorade contains flame retardant according to petition

Petition Claims Ingredient In Gatorade Is A Flame Retardant, Unsafe For Consumption Mary Beth Quirk, consumerist.com (Clean Wal-Mart)Gatorade is under fire from a new consumer petition claiming that the company’s beverage contains an unhealthy ingredient, brominated vegetable oil (or BVO), that was developed as a flame retardant. Opponents of the emulsifier, whi… Related articles Top … Continue reading Gatorade contains flame retardant according to petition

Researchers seek new drugs through evolution and local plant lore

Researchers seek new drugs through evolution and local plant lore John Timmer, arstechnica.com Some of the most suc­cess­ful drugs we know about have come from plants, includ­ing the can­cer drug Taxol, the malar­i­al treat­ment artemisinin, and even aspirin. The lat­ter two were iden­ti­fied because of their use in herbal reme­dies that… http://flpbd.it/IKidw Related articles Drug … Continue reading Researchers seek new drugs through evolution and local plant lore

How Sanofi Is Writing The Social Media Rules For Big Pharma

How Sanofi Is Writing The Social Media Rules For Big Pharma Without Running Afoul Of The FDA By Ben Paynter, fastcompany.com The biggest chal­lenge to treat­ing patients with dia­betes isn’t dol­ing out med­ica­tions, it’s mak­ing sure that peo­ple con­trol their habits. Poor diet and lack of exer­cise gen­er­al­ly cre­ate com­pli­ca­tions with the dis­ease. To com­bat … Continue reading How Sanofi Is Writing The Social Media Rules For Big Pharma

Personal genetics company seeks regulatory approval

Personal genetics company seeks regulatory approval Monya Baker, nature.com Per­son­al genet­ics com­pa­ny 23andMe announced Mon­day that it was seek­ing FDA approval for an ini­tial batch of seven health-related tests with scores more to fol­low. 23andMe, based in Moun­tain View, Cal­i­for­nia, mar­kets genet­ics test­… http://flpbd.it/usMr0 Related articles 23andMe's Tools Help Solve Ancestry Mystery (23andme.com) One Million … Continue reading Personal genetics company seeks regulatory approval

Biotechs engineer ancient organisms and speed product development

New Boston biotech companies such as Ginkgo BioWorks, Cambrian Innovation, and Manus Biosynthesis are tapping into ancient organisms and new IT capabilities to produce new solutions that are environmentally clean, US based, and fast with as little as 6 month product development life cycles. Gingko notes that 1/4 of their employees are software developers and … Continue reading Biotechs engineer ancient organisms and speed product development

IIR ePharma Summit

I've been a speaker a these conferences and they do a good job of covering new developments in life science and social media. IIR USA - Events Deliver Business. Related articles Viva the Healthcare (Social) Revolution! (gigipeterkin.com) Profiles of Drug Companies "Doing it Right": AstraZeneca (medmeme.com) #ePharma Annual Summit: leveraging innovative digital marketing strategies (pharmastrategyblog.com) … Continue reading IIR ePharma Summit

To improve drug safety, FDA should check its mixed-up files

This is really kind of sad...To improve drug safety, FDA should check its mixed-up files - The Boston Globe. Related articles FDA Issues New Cautionary Guidelines for Metal-on-Metal Hip Implants, Parker Waichman LLP Reports (prweb.com) DrugRisk Announces Updated Information on Mirena Lawsuits (prweb.com) FDA's Hazard Analysis and Risk-Based Preventive Controls for Human Food and Current … Continue reading To improve drug safety, FDA should check its mixed-up files

FDA final rule on safety info, but still no word on social media

FDA issues final rule on safety information during clinical trials This is an interesting announcement and reveals to me the fact that the FDA is coming to grips with the fact that the current process for reporting adverse events needs an overhaul including refining what qualifies as an AE and how they are reported. I … Continue reading FDA final rule on safety info, but still no word on social media

Dvorkin Camiel Lana – Massachusetts College of Pharmacy and Health Sciences

Interesting teacher on natural products at this school of pharmacy. Dvorkin Camiel Lana - Massachusetts College of Pharmacy and Health Sciences. Related articles Medical Humanities: Health & Disease in Culture, Popular Culture & American Culture Associations National Conference (CfP, Conference, Washington, DC, March 2013) (medicalhumanities.wordpress.com) Wal-Mart Gets Organic Beauty (fabsugar.com) Beauty Byte: Burt's Bees Wants … Continue reading Dvorkin Camiel Lana – Massachusetts College of Pharmacy and Health Sciences

CBI Social Media Pharma Conference Videos now available from Pixels and Pills

via http://www.pixelsandpills.com More videos and tweets from the CBI social media conference by Pixels and Pills are now posted on their site. The importance of trust and authenticity in patient/professional/industry interaction thru new online channels is emphasized. CBI Social Media Tools Conference Agenda Related articles Upcoming Pharma Conferences: December 2012 (medmeme.com) Pharma Marketing to Physicians … Continue reading CBI Social Media Pharma Conference Videos now available from Pixels and Pills

Why biotech and pharma companies are taking so long to adopt social media

Pharma companies have to deal with a lot of hurdles to allow people to collaborate with them online which may explain why they are such late adopters Regulations restrict social media use by biotechs, pharma - Mass High Tech Business News. Related articles Biotech, pharma warming up to Facebook (fiercebiotechit.com) Is FDA keeping social media … Continue reading Why biotech and pharma companies are taking so long to adopt social media

E-mails suggest Pfizer tried to suppress study on drug

E-mails suggest Pfizer tried to suppress study on drug - The Boston Globe. Here we go again. Not just Vioxx and the ghost writing scare but now also Neurontin. Emails can get your company in a lot of trouble Related articles Pfizer's Arthritis Treatment Wins Approval From US FDA - Bloomberg (bloomberg.com) Pfizer's Xeljanz story reveals why new drug development … Continue reading E-mails suggest Pfizer tried to suppress study on drug